🔍 RecallPedia

Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113;

Class I - Dangerous
🏥 Medical Devices Recalled: May 13, 2025 Philips North America Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Model Numbers: (1) 781270, (2) 782113; UDI-DI: (1) 00884838095083, (2) 00884838098909; Serial Numbers: (1) 17283, 17299, 17321, 17356, 17357, 17369, 17378, 17398, 17416, 17425, 17473, 17490, 17499, 17550, 17564, 17565, 17569, 17589, 17590, 17594, 23026, 24012, 24023, 24066, 24075, 24087, 24090, 24110, 34107, 34152, 35043, 35047, 35056, 38004, 38023, 38084, 38089, 38113, 38120, 38199, 38202, 38300, 38366, (2) 17252, 17258, 17346, 24039, 24077, 24146, 34131, 34212, 35071, 38197, 38234, 38291;
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Philips North America Llc
Reason for Recall:
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113;

Product Codes/Lot Numbers:

Model Numbers: (1) 781270, (2) 782113; UDI-DI: (1) 00884838095083, (2) 00884838098909; Serial Numbers: (1) 17283, 17299, 17321, 17356, 17357, 17369, 17378, 17398, 17416, 17425, 17473, 17490, 17499, 17550, 17564, 17565, 17569, 17589, 17590, 17594, 23026, 24012, 24023, 24066, 24075, 24087, 24090, 24110, 34107, 34152, 35043, 35047, 35056, 38004, 38023, 38084, 38089, 38113, 38120, 38199, 38202, 38300, 38366, (2) 17252, 17258, 17346, 24039, 24077, 24146, 34131, 34212, 35071, 38197, 38234, 38291;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1790-2025

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